Blog
RSS FeedPosted by Michael Wonder on 29 Dec 2020
Y-mAbs announces sale of priority review voucher
28 December 2020 - Y-mAbs Therapeutics today announced that it has entered into a definitive agreement to sell its priority ...
Posted by Michael Wonder on 26 Dec 2020
Novadip Biosciences receives rare paediatric disease priority review and orphan disease designation
23 December 2020 - Novadip Biosciences today announces that the U.S. FDA has granted rare paediatric disease designation and Orphan Drug ...
Posted by Michael Wonder on 21 Dec 2020
Sesen Bio submits completed biologics license application to the FDA for Vicineum and has requested priority review
21 December 2020 - BLA supported by strong Phase 3 VISTA trial data and positive analytical comparability data. ...
Posted by Michael Wonder on 17 Dec 2020
Novartis investigational oral therapy iptacopan (LNP023) receives FDA breakthrough therapy designation for PNH and rare paediatric disease designation for C3G
16 December 2020 - Iptacopan is in development for paroxysmal nocturnal haemoglobinuria, as well as C3 glomerulopathy and several other ...
Posted by Michael Wonder on 17 Dec 2020
FDA grants RMAT designation for Cook MyoSite’s investigational autologous muscle derived cells for urinary sphincter repair
17 December 2020 - Cook MyoSite today announced that the U.S. FDA has granted the regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 15 Dec 2020
U.S. FDA accepts new drug application for review, grants priority review for Takeda’s TAK-721 (budesonide oral suspension) for the treatment of eosinophilic oesophagitis
15 December 2020 - If approved, TAK-721 will be the first FDA approved treatment for the chronic inflammatory disease; Takeda plans ...
Posted by Michael Wonder on 10 Dec 2020
X4 Pharmaceuticals receives rare paediatric disease designation from FDA for mavorixafor for the treatment of WHIM syndrome
10 December 2020 - X4 Pharmaceuticals today announced that it has received rare paediatric disease designation from the U.S. FDA ...
Posted by Michael Wonder on 09 Dec 2020
US FDA accepts for priority review the biologics license application for Pfizer’s investigational 20 valent pneumococcal conjugate vaccine for adults 18 years of age and older
8 December 2020 - If approved, the vaccine will help protect adults against 20 serotypes responsible for the majority of invasive ...
Posted by Michael Wonder on 07 Dec 2020
Scynexis announces FDA acceptance and priority review of new drug application for oral ibrexafungerp for the treatment of vaginal yeast infections
7 December 2020 - 6 month Priority Review granted for ibrexafungerp with PDUFA target action date set for 1 June 2021. ...
Posted by Michael Wonder on 03 Dec 2020
Aeglea BioTherapeutics receives FDA rare paediatric disease designation for ACN00177 for the treatment of homocystinuria
1 December 2020 - Company eligible to receive priority review voucher upon FDA approval of ACN00177. ...
Posted by Michael Wonder on 02 Dec 2020
BridgeBio Pharma and Affiliate QED Therapeutics announce FDA acceptance of new drug application for infigratinib for the treatment of cholangiocarcinoma
1 December 2020 - Application will also be submitted for review in Australia and Canada under Project Orbis. ...
Posted by Michael Wonder on 28 Nov 2020
Polaryx Therapeutics receives both rare paediatric disease and orphan drug designations for the treatment of GM2 gangliosidosis with PLX-300
25 November 2020 - Polaryx Therapeutics announced today that it has received from the U.S. FDA both rare paediatric disease and ...
Posted by Michael Wonder on 21 Nov 2020
ADC Therapeutics announces FDA accepts biologics license application and grants priority review for loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma
20 November 2020 - Prescription Drug User Fee Act target action date of 21 May 2021. ...
Posted by Michael Wonder on 18 Nov 2020
FDA grants priority review for avalglucosidase alfa, a potential new therapy for Pompe disease
18 November 2020 - Regulatory submission based on positive data from two trials in patients with late-onset and infantile-onset Pompe disease, ...
Posted by Michael Wonder on 11 Nov 2020
Angiocrine Bioscience announces FDA regenerative medicine advanced therapy designation granted to AB-205 (universal E-CEL cell therapy) to treat organ vascular niche injuries for the prevention of severe toxicities in lymphoma patients undergoing curative high-dose therapy with autologous stem cell transplantation
11 November 2020 - Angiocrine Bioscience today announced that the U.S. FDA granted the regenerative medicine advanced therapy designation for AB-205, ...